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Lauren E Jones, Keun Ho Yang, Robert W Feldtman, Pablo V Uceda, Craig A Ferrara, Joseph M Caruso, Jasmine L Richmond, Samuel S Ahn
INTRODUCTION: We aimed to compare the safety and efficacy of 5 arterial closure devices in an outpatient endovascular surgery center. METHODS: We retrospectively reviewed all cases using femoral arterial access performed between January 2012 and December 2013. Five different arterial closure devices (AngioSeal, Perclose, StarClose, ExoSeal, and Mynx) were used by 7 endovascular surgeons. All femoral arteries were accessed with 6F sheaths under ultrasound guidance...
April 13, 2018: Annals of Vascular Surgery
Konstantin Hellwig, Susanne Regus
No abstract text is available yet for this article.
April 2018: European Journal of Vascular and Endovascular Surgery
Matthew A Elmasri, Stephen T Kee, John M Moriarty, Antoinette Gomes, Edward W Lee, Justin P McWilliams
INTRODUCTION: Vascular closure devices (VCDs) are commonly used to achieve hemostasis of arterial access sites, but there is little comparative data on the variety of VCDs currently in clinical use. We reviewed the VCD experience at our institution to determine the safest and most effective VCD. MATERIALS AND METHODS: Retrospective analysis of 907 consecutive arterial procedures in interventional radiology from June 2012 to June 2014 was performed. Five VCDs were used: Angio-Seal (n = 478), FISH (n = 56), Mynx (n = 56), Perclose (n = 61), and Starclose (n = 68)...
July 14, 2017: Journal of Vascular Access
Michael K Amponsah, Rajiv Tayal, Zain Khakwani, Michael Sinclair, Najam Wasty
The "preclose" technique employing two Perclose (P) devices is well established for large-bore artery (LBA) hemostasis. Occasionally, only one Perclose deploys successfully during the initial preclose because of arterial calcification necessitating the use of the crossover balloon technique to achieve hemostasis at the LBA. We sought to determine if the combined use of one Perclose and either one Angioseal or one Mynx vascular closure device (VCD) is a safe alternative closure technique large-bore arteriotomy closure...
June 2017: International Journal of Angiology: Official Publication of the International College of Angiology, Inc
Michael C Scott, Horace J Spencer, Ahsan T Ali, Mohammed M Moursi, Guillermo A Escobar, Lewis C Lyons, Matthew R Smeds
BACKGROUND: Vascular closure devices have been used to achieve hemostasis of percutaneous access sites following endovascular procedures, with reported decreased time for arterial control as well as decreased time to ambulation. We sought to determine rates and risk factors of postoperative bleeding complications and failures using these devices from a single institution experienced in the use of vascular closure devices. METHODS: All patients undergoing arterial endovascular procedures with percutaneous access between March 2010 and October 2015 at a single institution were identified and analyzed (n = 894)...
January 2018: Annals of Vascular Surgery
Frederic S Resnic, Arjun Majithia, Danica Marinac-Dabic, Susan Robbins, Henry Ssemaganda, Kathleen Hewitt, Angelo Ponirakis, Nilsa Loyo-Berrios, Issam Moussa, Joseph Drozda, Sharon-Lise Normand, Michael E Matheny
BACKGROUND: The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI). METHODS: We used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device, as compared with alternative approved vascular-closure devices, with data from the CathPCI Registry of the National Cardiovascular Data Registry...
February 9, 2017: New England Journal of Medicine
Nicolas W Shammas, Gail A Shammas, Thomas Harris, Cara M Voelliger, Andrew N Shammas, Michael Jerin
Bailout stenting of the common femoral artery (CFA) may become necessary with failed balloon angioplasty or atherectomy or in case of bleeding requiring a covered stent over the arteriotomy site. Reaccessing the CFA through a previously placed stent may occur during angiography. The safety and effectiveness of applying a closure device, or manual compression to achieve hemostasis through an accessed stented CFA are unknown. All patients in our practice that underwent CFA stenting were identified using billing records for 3 years (January 1, 2010-February 28, 2013)...
September 2016: International Journal of Angiology: Official Publication of the International College of Angiology, Inc
David Hutchings, Afzal Hayat, Arun Karunakaran, Nadim Malik
BACKGROUND: Femoral artery closure device use following percutaneous cannulation allows earlier mobilization, reduced staff burden, and improved comfort for patients compared with manual compression. The Mynx device (Access Closure, Inc), a novel extravascular closure device, uses a water-soluble non-thrombogenic polyethylene glycol plug. METHODS: We report retrospective analysis of success, complication rates, and associated factors in 432 consecutive patients undergoing elective outpatient coronary angiography in a single United Kingdom center...
March 2016: Journal of Invasive Cardiology
Nevin C Baker, Ricardo O Escarcega, Michael J Lipinski, Marco A Magalhaes, Edward Koifman, Sarkis Kiramijyan, Smita I Negi, Rebecca Torguson, Ron Waksman
OBJECTIVE: We evaluate the prevalence of complications and failure rates between the most commonly used "active" anchoring vascular closure device (VCD), AngioSeal™ and the "passive" anchoring VCD, Mynx™, in all-comers undergoing percutaneous coronary intervention (PCI). METHODS: A total of 4,074 patients between 2008 and 2014, representing an era when both devices were available, were included. Thirty-two percent were acute coronary syndromes (37% STEMI). VCD choice was at the operator's discretion and included AngioSeal (n = 2,910) or Mynx (1,164)...
February 2016: Journal of Interventional Cardiology
S Sanjay Srivatsa, Arjun Srivatsa, Taylor A Spangler
AIMS: Vascular closure device (VCD)-based venous closure has been anecdotally reported, but systematic evaluation of the reparative response of the vessel wall to venous closure is lacking. The need to control groin complications, and minimize risks associated with postponed sheath removal under conditions of persistent anticoagulation, has generated interest in the role of VCDs for venous access closure. We sought to characterize the vessel wall response to venous closure, both acutely and in delayed fashion at 30 days using angiography, ultrasound, and histology...
February 2015: Journal of Invasive Cardiology
Siddhartha Rao, Prashant Kaul, George A Stouffer
The Mynx (AccessClosure, Inc) is a vascular closure device that uses extravascular deployment of a self-expanding polyethylene glycol (PEG) sealant delivered during removal of the procedural sheath. An intravascular balloon is inflated at the arteriotomy site to prevent leakage of the sealant into the bloodstream. The complication rate with the Mynx vascular closure device is low, but there have been reports of distal embolization of the sealant. Optimal treatment of this complication is unknown, with limited published data relating only to surgical extraction...
August 2013: Journal of Invasive Cardiology
Ramesh Grandhi, Hilal Kanaan, Aalap Shah, Gillian Harrison, Christopher Bonfield, Tudor Jovin, Brian Jankowitz, Michael Horowitz
BACKGROUND AND PURPOSE: Percutaneous transfemoral arterial procedures rely on a variety of vascular closure methods. We studied closure success and complications after using the Mynx vascular closure device in cerebral neurovascular procedures. METHODS: We prospectively analyzed patients undergoing diagnostic cerebral angiogram or neurointervention with arteriotomy closure using the Mynx device. Patient demographics and procedural factors were recorded. Statistical analyses compared groups and identified predictors of device failure and complication...
July 2014: Journal of Neurointerventional Surgery
Ankur Gupta, Immad Sadiq, Steven Borer
Vascular closure devices are commonly used to obtain arterial access site closure after cardiovascular procedures. They are popular as they decrease time to hemostasis and ambulation while improving patient comfort by eliminating need for compression. However, complications due to vascular closure devices are not uncommon. We report a case of possible intravascular distal embolization of water-soluble PEG polymer that is deployed extravascular using the Mynx vascular closure device.
October 2012: Connecticut Medicine
Kyle M Fargen, Gregory J Velat, Matthew F Lawson, Charles A Ritchie, Christopher Firment, Brian L Hoh, Jeffery A Bennett, J Mocco
INTRODUCTION: There have been recent reports of high vascular complication rates after the use of the Mynx vascular closure device (VCD). At our institution, vascular complications due to these devices have rarely been encountered. A study was undertaken to retrospectively compare angiographic abnormalities seen after femoral artery closure by both the Mynx and AngioSeal VCDs to provide further insight into the risks associated with VCDs. METHODS: All adult patients who underwent deployment of either a Mynx or AngioSeal VCD and subsequently underwent repeat angiography within the next 30 days between 1 July 2010 and 1 April 2011 were reviewed...
March 2013: Journal of Neurointerventional Surgery
Kyle M Fargen, Brian L Hoh, J Mocco
BACKGROUND AND PURPOSE: The Mynx M5 (AccessClosure, Inc., Mountain View, California, USA), a novel vascular closure device (VCD) utilizing extravascular synthetic sealant, may effectively seal the arteriotomy while reducing the pain associated with arteriotomy closure seen with other VCDs. To date, no studies exist comparing the pain associated with deployment between differing VCDs as a primary end point. METHODS: A blinded, randomized controlled trial was performed comparing the Mynx and a popular VCD that utilizes a self-tightening suture, the Angio-Seal Evolution (St Jude Medical, St Paul, Minnesota, USA)...
September 2011: Journal of Neurointerventional Surgery
Shishir Murarka, Richard R Heuser
AIM: left ventricular direct access and sheath placement through a minithoracotomy has been utilized to allow minimally invasive valvular surgery. One potential problem encountered is the closure of the ventricular puncture incision in a beating heart. Our aim was to develop a sutureless closure technique that does not leave behind a foreign body exposed on the endocardial surface. MATERIALS & METHODS: we sought to evaluate this concept in vivo in the porcine model...
November 2010: Future Cardiology
Bryan G Schwartz, Steven Burstein, Christina Economides, Robert A Kloner, David M Shavelle, Guy S Mayeda
Vascular access-site complications are an important cause of morbidity following catheterization procedures. Manual compression is the "gold standard" in achieving hemostasis of an arteriotomy site; however, manual compression is limited by the need to interrupt anticoagulation, prolonged bed rest, patient discomfort and time demands for healthcare providers. Vascular closure devices (VCDs) improve patient comfort, free medical staff resources and shorten the time needed for hemostasis, ambulation and discharge...
December 2010: Journal of Invasive Cardiology
J D Fields, K C Liu, D S Lee, S J Gonda, A Dogan, S H Gultekin, G M Nesbit, B D Petersen, S L Barnwell
BACKGROUND AND PURPOSE: Devices to close a femoral arteriotomy are frequently used after catheterization for interventional radiology and cardiac procedures to decrease the time to hemostasis and ambulation and, potentially, to decrease local complications. The Mynx vascular closure device uses a sealant designed to occlude the access tract, resulting in hemostasis. MATERIALS AND METHODS: We retrospectively reviewed all cases in which the Mynx device was used and for which follow-up angiography was available...
October 2010: AJNR. American Journal of Neuroradiology
Sonya Noor, Susan Meyers, Richard Curl
BACKGROUND: Access site complications requiring emergent surgery following femoral catheterization expose patients to additional morbidities and mortality. We observed a significant decrease in such surgeries after the Mynx device was introduced. METHODS: A retrospective review of surgeries performed as a complication of 6F & 7F femoral cardiac and peripheral catheterization was done. Rates of surgeries among 3 closure methods were compared during the study period July 2006 to July 2008 (Mynx, AngioSeal, and manual/mechanical compression)...
July 2010: Vascular and Endovascular Surgery
Shah Azmoon, Anthony L Pucillo, Wilbert S Aronow, Ramin Ebrahimi, Joseph Vozzolo, Archana Rajdev, Kumar Kalapatapu, Jae H Ro, Craig Hjemdahl-Monsen
UNLABELLED: We investigated the prevalence of vascular complications after PCI following hemostasis in 190 patients (67% men and 33% women, mean age 64 years) treated with the AngioSeal vascular closure device (St. Jude Medical, Austin, Texas) versus 238 patients (67% men and 33% women, mean age 64 years) treated with the Mynx vascular closure device (AccessClosure, Mountain View, California). RESULTS: Death, myocardial infarction or stroke occurred in none of the 190 patients (0%) treated with the AngioSeal versus none of 238 patients (0%) treated with the Mynx...
April 2010: Journal of Invasive Cardiology
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